PINWORM INFECTION
IS EXTREMELY CONTAGIOUS1,2

According to the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP) Red Book, prevalence can reach up to 50% in families with an infected child.2,3

Why breaking the cycle can be difficult

  • One female pinworm can lay up to 10,000 highly infective eggs on the perianal folds of the infected person2
  • Pinworm eggs are sticky and resilient. They can survive on indoor surfaces for up to 3 weeks and are easily transmitted to other household members, causing pinworm infections to spread within infected families2
  • Eggs can become airborne and inhaled or deposited onto food and swallowed by other household members4

Household objects that act as fomites for pinworm eggs include2:

Pinworm is easily spread to shared surfaces like door knobs.

Advice to caregivers

  • Infected people should shower in the morning to remove infective pinworm eggs2
  • Frequently changing the underclothes, bedclothes, and bedding of an infected person may decrease egg contamination2
  • Parents and caregivers should be cautioned not to shake out bed linens, blankets, and towels during an outbreak2
  • Specific hygiene measures such as avoiding scratching of the perianal area, practicing good hygiene, and keeping fingernails short may decrease the risk of continued transmission2,4
    • While important, personal hygiene and housecleaning alone are unlikely to stop an outbreak5

IMPORTANT SAFETY INFORMATION

Contraindication: EMVERM is contraindicated in persons with a known hypersensitivity to the drug or its excipients (mebendazole, microcrystalline cellulose, corn starch, anhydrous lactose, sodium starch glycolate, magnesium stearate, stearic acid, sodium lauryl sulfate, sodium saccharin, and FD&C Yellow #6).

Warnings and Precautions:

  • Risk of convulsions: Convulsions in infants below the age of 1 year have been reported

  • Hematologic effects: Neutropenia and agranulocytosis have been reported in patients receiving mebendazole at higher doses and for prolonged duration. Monitor blood counts in these patients

  • Metronidazole and serious skin reactions: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole

Adverse Reactions from Clinical Trials*: Anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting, rash.
Adverse Reactions from Postmarketing Experience with Mebendazole*: Agranulocytosis, neutropenia, hypersensitivity including anaphylactic reactions, convulsions, dizziness, hepatitis, abnormal liver tests, glomerulonephritis, Stevens-Johnson syndrome/toxic epidermal necrolysis, exanthema, angioedema, urticaria, alopecia.
*Includes mebendazole formulations, dosages and treatment duration other than EMVERM 100 mg chewable tablet.

Drug Interactions: Concomitant use of EMVERM and metronidazole should be avoided.

Use in Specific Populations:

  • Pregnancy: Mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages. However, there are risks to the mother and fetus associated with untreated helminthic infection during pregnancy.

  • Lactation: Limited data from case reports demonstrate that a small amount of mebendazole is present in human milk following oral administration. There are no reports of effects on the breastfed infant.

  • Pediatric Use: The safety and effectiveness of EMVERM 100 mg chewable tablet has not been established in pediatric patients less than two years of age.

  • Geriatric Use: Clinical studies of mebendazole did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

Overdosage: In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported: alopecia, reversible transaminase elevations, hepatitis, agranulocytosis, neutropenia, and glomerulonephritis.

  • Symptoms and signs of overdose: In the event of accidental overdose, gastrointestinal signs/symptoms may occur

  • Treatment of overdose: There is no specific antidote

Patient Counseling: Healthcare professionals should advise the patient to read the FDA-approved patient labeling (Patient Information). Advise patients that:

  • Taking EMVERM and metronidazole together may cause serious skin reactions and should be avoided.

  • EMVERM can be taken with or without food.

INDICATION

EMVERM is indicated for the treatment of patients two years of age and older with gastrointestinal infections caused by Ancylostoma duodenale (hookworm), Ascaris lumbricoides (roundworm), Enterobius vermicularis (pinworm), Necator americanus (hookworm), and Trichuris trichiura (whipworm).

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for Full Prescribing Information.

References:
1. Kucik CJ, Martin GL, Sortor BV. Am Fam Physician. 2004;69(5):1161-1168. 2. American Academy of Pediatrics. Red Book: 2018-2021 Report of the Committee on Infectious Diseases. 31st ed. Itasca, IL: American Academy of Pediatrics; 2018:634-635, 994. 3. Treatment. Centers for Disease Control and Prevention website. https://www.cdc.gov/ parasites/pinworm/treatment.html. Updated August 30, 2016. Accessed March 20, 2019. 4. Enterobiasis. Centers for Disease Control and Prevention website. https://www.cdc.gov/dpdx/enterobiasis/index.html. Updated December 8, 2017. Accessed March 20, 2019. 5. Maguire JH. Intestinal nematodes (roundworms). In: Bennett JE, Dolin R, Blaser MJ, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 8th ed. Philadelphia, PA: Elsevier Saunders; 2015:3199-3207.e2.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Contraindication: EMVERM is contraindicated in persons with a known hypersensitivity to the drug or its excipients (mebendazole, microcrystalline cellulose, corn starch, anhydrous lactose, sodium starch glycolate, magnesium stearate, stearic acid, sodium lauryl sulfate, sodium saccharin, and FD&C Yellow #6).

Warnings and Precautions:

  • Risk of convulsions: Convulsions in infants below the age of 1 year have been reported

  • Hematologic effects: Neutropenia and agranulocytosis have been reported in patients receiving mebendazole at higher doses and for prolonged duration. Monitor blood counts in these patients

  • Metronidazole and serious skin reactions: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole

Adverse Reactions from Clinical Trials*: Anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting, rash.
Adverse Reactions from Postmarketing Experience with Mebendazole*: Agranulocytosis, neutropenia, hypersensitivity including anaphylactic reactions, convulsions, dizziness, hepatitis, abnormal liver tests, glomerulonephritis, Stevens-Johnson syndrome/toxic epidermal necrolysis, exanthema, angioedema, urticaria, alopecia.
*Includes mebendazole formulations, dosages and treatment duration other than EMVERM 100 mg chewable tablet.

Drug Interactions: Concomitant use of EMVERM and metronidazole should be avoided.

Use in Specific Populations:

  • Pregnancy: Mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages. However, there are risks to the mother and fetus associated with untreated helminthic infection during pregnancy.

  • Lactation: Limited data from case reports demonstrate that a small amount of mebendazole is present in human milk following oral administration. There are no reports of effects on the breastfed infant.

  • Pediatric Use: The safety and effectiveness of EMVERM 100 mg chewable tablet has not been established in pediatric patients less than two years of age.

  • Geriatric Use: Clinical studies of mebendazole did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

Overdosage: In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported: alopecia, reversible transaminase elevations, hepatitis, agranulocytosis, neutropenia, and glomerulonephritis.

  • Symptoms and signs of overdose: In the event of accidental overdose, gastrointestinal signs/symptoms may occur

  • Treatment of overdose: There is no specific antidote

Patient Counseling: Healthcare professionals should advise the patient to read the FDA-approved patient labeling (Patient Information) Advise patients that:

  • Taking EMVERM and metronidazole together may cause serious skin reactions and should be avoided.

  • EMVERM can be taken with or without food.

INDICATION

EMVERM is indicated for the treatment of patients two years of age and older with gastrointestinal infections caused by Ancylostoma duodenale (hookworm), Ascaris lumbricoides (roundworm), Enterobius vermicularis (pinworm), Necator americanus (hookworm), and Trichuris trichiura (whipworm).

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for Full Prescribing Information.

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